Condition category
Circulatory System
Date applied
09/05/2014
Date assigned
17/07/2014
Last edited
17/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Intermittent claudication is pain in the leg brought on by walking and is caused by poor blood flow to the muscles. It is intermittent because it only comes on with walking or exercise and goes away when you rest. In this study, we want to find out the specific effects of rocker sole shoes and orthotic designs on the walking of people with intermittent claudication. Four different types of footwear and one orthotic device will be tested. The results of this study will tell us if specific shoe features are linked to specific changes in the balance of forces at the legs during walking and to resulting changes in calf muscle activity. These results will be used to design shoes for individuals with intermittent claudication that will specifically target their calf muscle activity in order to increase their pain-free walking distance and therefore allow them to be more mobile. The same concept will be used for the design of shoes that exercise the calf muscles to improve circulation at the lower limb. Such shoes can be very important assets to the management of intermittent claudication.

Who can participate?
The study aims to recruit 40 people diagnosed with lower limb intermittent claudication and 40 healthy adults.

What does the study involve?
Participants will be walking in four different type of shoes in a random order, across a gait (walking) laboratory. The data on their gait and muscle activity are collected and analysed to see if the type of shoe has any effect on their walking.

What are the possible benefits and risks of participating?
The participants will not have any direct benefit from this study. However, the results will be used in the design of shoes for people with intermittent claudication, hence improving their quality of life in the future. During the tests there is a chance that patient participants may feel aching in their calves that they sometimes experience when they walk, but we do not expect this to occur because we will not be asking them to walk very far. Participants will be able to take frequent rests. Because the shoes we are testing are different to the ones participants usually wear they may need some time to get used to them. They will therefore be given as much time as they need to get comfortable and used to wearing the shoes. Sometimes, people can feel unsteady in new footwear, but there are no reported risks of falls or trips in these shoes. Whilst we do not expect it to be necessary, if they prefer, a person will be able to walk close to them during the walking tests.

Where is the study run from?
We will be recruiting through an NHS clinic (Linacre centre, Wigan, UK) and healthy individuals through posters and a university volunteer database.

When is the study starting and how long is it expected to run for?
The study started in June 2014 and will run for 6 months.

Who is funding the study?
1. University of Salford (UK)
2. The Wrightington, Wigan and Leigh NHS Foundation Trust (UK)

Who is the main contact?
Prof. Richard Jones
R.K.Jones@salford.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Chris Nester

ORCID ID

Contact details

PO 32 Brian Blatchford building
University of Salford
Salford
Manchester
M5 4WT
United Kingdom
+44 (0)161 295 2275
c.j.nester@salford.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HSCR13/91

Study information

Scientific title

An understanding of footwear and orthotic modifications on gait biomechanics in patients with intermittent claudication 

Acronym

Study hypothesis

1. Individuals with intermittent claudication walk differently to healthy counterparts and have weaker calf muscles
2. Rocker sole shoes will significantly change the gait of individuals with intermittent claudication and will decrease the work required by the calf muscles

Ethics approval

NRES Committee South East Coast - Brighton and Sussex; 28/03/2014; ref. 14/LO/0382

Study design

Randomised case control study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Peripheral arterial disease (PAD)

Intervention

Subjects will perform trials in a custom standard shoe, four rocker sole shoes (3 curve rocker, 2 curve rocker, 1 curve rocker, MBT shoe) and a standard ankle foot orthosis. 

Participants with PAD will be walking in a control shoe, a 2 three-curve rocker sole shoes, a 2 curve rocker sole shoe, and in a shoe-orthotic combination with all three shoes. The orthotic is a regular solid AFO set at 90 degrees. The sequence in which they will wear the interventions will be pre-randomised using statistical software (minitab).The testing will take place at the University of Salford podiatry gait laboratory.
With regard to outcome measures, data will be collected using a camera capture system (Qualysis), force plates and wired EMG system (Norax) as participants walk across the room. All data will be collected in a single 3-hour session. This data will be processed using Visual 3D software, followed by matlab processing. Statistical analysis will be done using Minitab software.

Healthy participants will only walk in the control shoe. The same data will be collected on them using the same systems. This is a shorter, 1-hour session.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. External ankle moment will allow us to determine the forces applied at the ankle throughout stance phase. This will 
give a comprehensive picture of the forces exerted on the calf muscles in this time­frame
2. EMG muscle activation will allow us to observe when during the gait cycle and in response to which forces specific 
muscles of the calf are activated. This will allow us to determine the effectiveness of the shoes in altering calf muscle 
activity as well as potential compensations for the lack of calf muscle strength by more proximal muscle groups

Secondary outcome measures

1. Measurement of external knee flexion moment will allow more accurate computation of forces exerted on the calf muscles 
2. Measurement of external hip flexion moment will ensure identification of potential compensations at the proximal joints

Overall trial start date

15/06/2014

Overall trial end date

15/11/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants admitted to the study will range between the ages of 50 and 75.
2. Participants must have a formal diagnosis of intermittent claudication of at least 3 months confirmed by a consultant vascular surgeon. This diagnosis will be derived using colour-flow duplex scan, medical history and examination, and absence or reduction in foot pulses, an ankle brachial pressure index (ABPI) of less than 0.8.
3. Participants must be able to walk a minimum of 100 m or perform 2 minutes of continuous walking unaided.
4. Healthy participants must be aged 50 or over.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

40 individuals with intermittent claudication and 40 healthy counterparts will be recruited

Participant exclusion criteria

1. Active or a prior history of foot ulcers
2. Significant foot deformities necessitating use of foot orthoses
3. Self-reported complete neuropathy in their feet (a reported lack of diabetes will be verified through a foot sensation test)
4. Surgery in the previous 6 months
5. Pain in their lower limbs or back with a cause unrelated to PAD/IC
6. Painful knee, ankle or hip osteoarthritis
7. Total reliance on walking aids
8. Prior lower limb joint replacement
9. Morbidly obese (BMI>35). Marker placement relies on identification of joint centres and bony landmarks and these must be easily palpated by hand.
10. Healthy participants must not have any of the following: significant pain in the legs when walking, prior injury to the legs or spine, diabetes, foot deformities, prior joint replacement or major orthopaedic surgery.

Recruitment start date

15/06/2014

Recruitment end date

15/11/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

PO 32 Brian Blatchford building
Salford, Manchester
M5 4WT
United Kingdom

Sponsor information

Organisation

University of Salford (UK)

Sponsor details

c/o Susan Braid
Allerton A120
Salford
Manchester
M6 6PU
United Kingdom
+44 (0)161 295 2203
s.braid@salford.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Salford (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Wrightington, Wigan and Leigh NHS Foundation Trust (UK); Ref: HSCR13/91

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes